Hepatocellular Carcinoma (HCC)Phase 1NCT07364357
A Phase I Study of CREPT-618 in Locally Advanced HCC
A Phase 1 study testing gene therapy in people with Hepatocellular Carcinoma (HCC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a single-center, open-label, dose-escalation Phase I clinical study designed to evaluate the safety (incidence of adverse events), maximum tolerated dose (MTD), optimal biological dose (OBD), and recommended Phase II dose (RP2D) of CREPT-618 in adult patients aged 18-75 with locally advanced hepatocellular… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- gene therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2025to 15 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years old.
- Diagnosis: Patients with histologically confirmed locally or advanced hepatocellular carcinoma (HCC) (BCLC stage C or ineligible for curative treatment).
- Hepatitis B Status: Inactive hepatitis B virus infection with negative HBV-DNA viral load.
- Informed Consent: Ability to understand and voluntarily sign the informed consent form.
- Prior Treatment: Failed prior standard treatment.
- ECOG Performance Status: ECOG performance status score of 0-2.
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- Measurable Disease: Presence of at least one measurable lesion according to RECIST 1.1 criteria.
- Biomarker Status: Must be able to provide at least six unstained slides for testing, confirming both CREPT and ASGPR receptor positivity in liver cancer tissue. Alternatively, a tumor biopsy can be performed to confirm CREPT and ASGPR double positivity. H-score must be greater than 50% with a staining intensity of 2+.
- Organ Function: Acceptable major organ function as defined by the following laboratory values: Platelets ≥ 70 × 10^9/L Neutrophils ≥ 1.5 × 10^9/L Hemoglobin ≥ 90 g/L Prothrombin time prolongation ≤ 6 seconds Renal function: Creatinine clearance (Ccr) > 50 ml/min (calculated using the Cockcroft-Gault formula).
- Life Expectancy: Expected life expectancy of at least 3 months.
- Contraception: Male and female patients of childbearing potential must agree to use effective contraception (hormonal, barrier, or abstinence) during the study and for at least 6 months after the last dose of the study drug. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment.
- Compliance: Patients must be compliant and willing to adhere to follow-up procedures.
Who cannot join
- Prior Treatment:
- Received systemic anti-tumor therapy (chemotherapy, radiotherapy, biological therapy, cytokine therapy, immunotherapy) or participated in other therapeutic clinical studies within 4 weeks prior to the first dose of the study drug. This includes nitrosourea drugs or mitomycin C within 6 weeks prior to the first dose. Exceptions: i) Oral fluoropyrimidine drugs or small molecule targeted agents received more than 2 weeks or 5 half-lives before the first dose (whichever is longer, but not exceeding 28 days).
- Traditional Chinese medicine for anti-tumor treatment received more than 2 weeks prior to the first dose.
- Palliative bone-directed radiotherapy. b) Planned to undergo major surgery within 28 days before the start of the study treatment (diagnostic biopsies are permitted).
- Received systemic immunostimulants within 4 weeks or 5 half-lives (whichever is longer) prior to enrollment.
- Used systemic corticosteroids (prednisone > 10 mg/d or equivalent dose) or other immunosuppressive drugs within 14 days before the start of study treatment. Exceptions include topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids, or short-term use of corticosteroids for prophylactic purposes.
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- Autoimmune Disease: Active autoimmune disease or a history of autoimmune disease within the past 2 years. Exceptions: vitiligo, Graves' disease, Hashimoto's disease, or psoriasis that did not require systemic treatment within the past 2 years.
- Severe Liver Decompensation: Presence of any of the following symptoms or abnormal indicators of severe liver function decompensation: Refractory ascites (unresponsive to diuretics or requiring frequent paracentesis); Hepatic encephalopathy ≥ Grade 2 (West Haven criteria); History of or current spontaneous bacterial peritonitis (SBP);Hepatorenal syndrome; History of esophagogastric variceal bleeding (within the last 3 months); Hepatic hydrothorax, hepatopulmonary syndrome, portal vein thrombosis (complete occlusion), or other severe liver-related complications;
- Laboratory Values: Total bilirubin > 3 mg/dL (51.3 μmol/L) Albumin < 2.8 g/dL (28 g/L) INR > 2.3 or prothrombin time prolongation > 6 seconds ALT or AST > 3 times the upper limit of normal (ALT > 120 U/L, AST > 105 U/L) Serum sodium < 130 mmol/L Serum creatinine > 1.5 mg/dL (133 μmol/L);
- Severe Infection/Comorbidities:
- Positive for HIV or a known history of AIDS.
- Positive for Hepatitis C virus (anti-HCV or HCV-RNA). (Patients with Hepatitis B may be included if they are receiving and willing to continue antiviral treatment according to local guidelines).
- Interstitial lung disease, obstructive lung disease, active bronchospasm, or oxygen saturation < 93% ("pulmonary insufficiency"), or any other active or severe pulmonary disease that may cause severe respiratory distress.
- Unresolved Toxicity: Unresolved toxicities from prior anti-cancer treatment that have not recovered to ≤ Grade 1. Exceptions may include toxicities judged by the investigator to not pose a safety risk (e.g., alopecia, Grade 2 peripheral neuropathy, or stable hypothyroidism on hormone replacement therapy).
- Comorbidities: Uncontrolled diabetes (fasting blood glucose > 200 mg/dL or 11.1 mmol/L), severe cardiovascular disease (e.g., myocardial infarction within the last 6 months, unstable angina, NYHA Class III-IV heart failure), etc.
- Brain Metastases: Patients with symptomatic active brain or meningeal metastases, primary central nervous system (CNS) tumors, or CNS metastases that have failed local treatment. Patients with asymptomatic or stable CNS metastases for at least 28 days without steroid use and confirmed as stable on a screening scan may be included.
- Other Malignancies: A history of other active malignancies within 5 years prior to enrollment, excluding basal cell or squamous cell skin cancer, cervical carcinoma in situ, papillary thyroid cancer, ductal carcinoma in situ of the breast, or other malignancies for which the patient has been disease-free for more than 5 years.
- Vaccination: Received live attenuated vaccines within 28 days prior to the first dose of the study drug. During the study, no vaccines other than inactivated vaccines (e.g., inactivated influenza vaccine) are permitted.
- Prior Immunotherapy: History of immunotherapy (including anti-CTLA-4/anti-PD-L1 or other agents) with any unresolved irAEs > Grade 1 prior to the first dose, or a history of irAEs ≥ Grade 3. Also, known allergy to any component of the CREPT-618 formulation.
- Other: Received liver transplant evaluation or planned liver transplant within 4 weeks prior to the first dose, or planned during the study.
- Psychological/Compliance Issues: Patients with a mental disorder or poor compliance.
- Substance Abuse: Known history of alcohol or drug abuse.
- Pregnancy/Lactation: Pregnant or lactating female patients. Pregnancy is defined as a positive laboratory test for human chorionic gonadotropin (hCG) within 7 days before starting the study drug.
- Investigator Discretion: Any other severe physical or mental illness or abnormal laboratory finding that the investigator believes makes the patient unsuitable for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Peiwen Ma, M.D., +8619520426360, mapeiwen@cicams.ac.cn
Ning Li, M.D.
About this study
Official title: An Open-label Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of CREPT-618 in Patients With Locally Advanced Hepatocellular Carcinoma
This is a single-center, open-label, dose-escalation Phase I clinical study designed to evaluate the safety (incidence of adverse events), maximum tolerated dose (MTD), optimal biological dose (OBD), and recommended Phase II dose (RP2D) of CREPT-618 in adult patients aged 18-75 with locally advanced hepatocellular carcinoma who have failed standard treatment.
The study adopts a 3+3 dose escalation design for dose climbing, primarily consisting of three dose groups: low dose, medium dose, and high dose. Patient enrollment and dose escalation in each group will be based on safety evaluation results. Pharmacokinetic parameters and preliminary efficacy indicators will also be assessed.
Read the detailed description
This is a single-center, open-label, dose-escalation Phase I clinical study designed to evaluate the safety (incidence of adverse events), maximum tolerated dose (MTD), optimal biological dose (OBD), and recommended Phase II dose (RP2D) of CREPT-618 in adult patients aged 18-75 with locally advanced hepatocellular carcinoma who have failed standard treatment.
The study employs a 3+3 dose escalation design for dose titration, consisting of three primary dose groups: low dose, medium dose, and high dose. Patient enrollment and dose escalation in each cohort will be based on safety evaluation results. Pharmacokinetic parameters and preliminary efficacy indicators will also be assessed.
The study design includes three dose groups, with a total of 7-13 patients. The dose groups are divided into low dose (sentinel dose, 0.5 mg/kg), medium dose (1.5 mg/kg), and high dose (4.5 mg/kg). The low-dose group (sentinel) will enroll 1 patient; the medium-dose group, 3-6 patients; and the high-dose group, 3-6 patients. Each patient will receive single or multiple subcutaneous injections of CREPT-618 administered once every two weeks. Assessment timepoints include safety evaluations, pharmacokinetic (PK) sampling, and efficacy evaluations.
Starting with the sentinel dose, one sentinel patient will be enrolled in the low-dose group and observed for up to 28 days. If no dose-limiting toxicity (DLT) occurs in the sentinel patient, enrollment will proceed to the medium-dose group. Initially, one patient will be enrolled in this group. If no DLT is observed, two additional patients will be enrolled in the medium-dose group. If no DLT occurs in any of these patients, escalation to the high-dose group will begin. If one DLT occurs, one additional patient will be enrolled in the same dose group; if ≥2 DLTs occur, the previous dose will be determined as the MTD.
The high-dose group will enroll three patients, with the possibility of expanding to six if needed. To ensure the trial can escalate to the anticipated effective dose, if no DLTs are observed in the low-, medium-, or high-dose groups, and no changes are observed in objective response rate or liver function indicators, the dose may be adjusted to 9 mg/kg. One patient will be enrolled at this dose level; if no DLT occurs, two additional patients will be enrolled.
If disease progression is observed at the 6-week efficacy assessment, subsequent treatment will involve CREPT-618 administration every two weeks in combination with pembrolizumab. Based on a comprehensive evaluation of safety and pharmacodynamic (PD) data from existing patients, the investigator may adjust the dosing frequency. If higher doses are tolerated and potential benefits are anticipated, dose escalation to a higher dose group is permitted within the same subject (allowed only once).
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- gene therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene therapyGenetic
Using small nucleic acid drug to targeting CREPT
| Study group | Role | What they receive |
|---|---|---|
| CREPT-618 | Experimental | The study employs a 3+3 dose escalation design for dose titration, consisting of three primary dose groups: low dose(sentinel dose), medium dose, and high dose.Starting with the sentinel dose, one sentinel patient will be enrolled in the low-dose group and observed for up to 28 days. If no dose-limiting toxicity (DLT) occurs in the sentinel patient, enrollment will proceed. To ensure the trial can escalate to the anticipated effective dose, if no DLTs are observed in the low-, medium-, or high-dose groups, and no changes are observed in objective response rate or liver function indicators, the dose may be adjusted to a new dose. Receives: Genetic: gene therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
Safety: Incidence of adverse events (AEs) (graded according to CTCAE v5.0)， Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (10)
Pharmacokinetics (PK)
Pharmacokinetics (PK): Peak plasma concentration (Cmax) of CREPT-618 in plasma.
Measured: baseline and after treatment (0.5h, 1h, 2h, 4h, 8h, 24h for first dose, 1h for second dose(day15) and third dose(day 29))
Pharmacokinetics (PK)
half-life (t1/2) of CREPT-618 in plasma.
Measured: baseline and after treatment (0.5h, 1h, 2h, 4h, 8h, 24h for first dose, 1h for second dose(day15) and third dose(day 29))
Pharmacokinetics (PK)
area under the curve (AUC0-∞) of CREPT-618 in plasma.
Measured: baseline and after treatment (0.5h, 1h, 2h, 4h, 8h, 24h for first dose, 1h for second dose(day15) and third dose(day 29))
Pharmacodynamics(PD)
Analysis of changes in CREPT protein expression after treatment using immunohistochemical staining of puncture liver tumor tissue.
Measured: baseline and 6 weeks after treatment
Preliminary Efficacy
Tumor objective response rate (ORR, RECIST 1.1, iRECIST)
Measured: about 2 years
Preliminary Efficacy
disease control rate (DCR)
Measured: about 2 years
Preliminary Efficacy
progression-free survival (PFS)
Measured: about 2 years
Preliminary Efficacy
Measure quality of life score by EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire)
Measured: at baseline and 15 days after treatment.
preliminary efficacy
changes in serum AFP levels
Measured: about 2 years
Preliminary Efficacy
Measure quality of life score by EORTC QLQ-HCC18 (EORTC Quality of Life Questionnaire - Hepatocellular Carcinoma 18 )
Measured: Baseline and 15 days after first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start15 Sep 2025
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ning Li, M.D., Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364357
- Sponsor's protocol ID
- HY-618-IIT01
- Status last verified
- Jan 2026
- First submitted
- 16 Sep 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of CREPT-618 in Patients With Locally Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07364357
- Acronym / sponsor ID
- HY-618-IIT01
- Conditions
- Hepatocellular Carcinoma (HCC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center, open-label, dose-escalation Phase I clinical study designed to evaluate the safety (incidence of adverse events), maximum tolerated dose (MTD), optimal biological dose (OBD), and recommended Phase II dose (RP2D) of CREPT-618 in adult patients aged 18-75 with locally advanced hepatocellular carcinoma who have failed standard treatment.
The study adopts a 3+3 dose escalation design for dose climbing, primarily consisting of three dose groups: low dose, medium dose, and high dose. Patient enrollment and dose escalation in each group will be based on safety evaluation results. Pharmacokinetic parameters and preliminary efficacy indicators will also be assessed.
Detailed description
This is a single-center, open-label, dose-escalation Phase I clinical study designed to evaluate the safety (incidence of adverse events), maximum tolerated dose (MTD), optimal biological dose (OBD), and recommended Phase II dose (RP2D) of CREPT-618 in adult patients aged 18-75 with locally advanced hepatocellular carcinoma who have failed standard treatment.
The study employs a 3+3 dose escalation design for dose titration, consisting of three primary dose groups: low dose, medium dose, and high dose. Patient enrollment and dose escalation in each cohort will be based on safety evaluation results. Pharmacokinetic parameters and preliminary efficacy indicators will also be assessed.
The study design includes three dose groups, with a total of 7-13 patients. The dose groups are divided into low dose (sentinel dose, 0.5 mg/kg), medium dose (1.5 mg/kg), and high dose (4.5 mg/kg). The low-dose group (sentinel) will enroll 1 patient; the medium-dose group, 3-6 patients; and the high-dose group, 3-6 patients. Each patient will receive single or multiple subcutaneous injections of CREPT-618 administered once every two weeks. Assessment timepoints include safety evaluations, pharmacokinetic (PK) sampling, and efficacy evaluations.
Starting with the sentinel dose, one sentinel patient will be enrolled in the low-dose group and observed for up to 28 days. If no dose-limiting toxicity (DLT) occurs in the sentinel patient, enrollment will proceed to the medium-dose group. Initially, one patient will be enrolled in this group. If no DLT is observed, two additional patients will be enrolled in the medium-dose group. If no DLT occurs in any of these patients, escalation to the high-dose group will begin. If one DLT occurs, one additional patient will be enrolled in the same dose group; if ≥2 DLTs occur, the previous dose will be determined as the MTD.
The high-dose group will enroll three patients, with the possibility of expanding to six if needed. To ensure the trial can escalate to the anticipated effective dose, if no DLTs are observed in the low-, medium-, or high-dose groups, and no changes are observed in objective response rate or liver function indicators, the dose may be adjusted to 9 mg/kg. One patient will be enrolled at this dose level; if no DLT occurs, two additional patients will be enrolled.
If disease progression is observed at the 6-week efficacy assessment, subsequent treatment will involve CREPT-618 administration every two weeks in combination with pembrolizumab. Based on a comprehensive evaluation of safety and pharmacodynamic (PD) data from existing patients, the investigator may adjust the dosing frequency. If higher doses are tolerated and potential benefits are anticipated, dose escalation to a higher dose group is permitted within the same subject (allowed only once).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CREPT-618 | Experimental | Genetic: gene therapyThe study employs a 3+3 dose escalation design for dose titration, consisting of three primary dose groups: low dose(sentinel dose), medium dose, and high dose.Starting with the sentinel dose, one sentinel patient will be enrolled in the low-dose group and observed for up to 28 days. If no dose-limiting toxicity (DLT) occurs in the sentinel patient, enrollment will proceed. To ensure the trial can escalate to the anticipated effective dose, if no DLTs are observed in the low-, medium-, or high-dose groups, and no changes are observed in objective response rate or liver function indicators, the dose may be adjusted to a new dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age: 18-75 years old.
- Diagnosis: Patients with histologically confirmed locally or advanced hepatocellular carcinoma (HCC) (BCLC stage C or ineligible for curative treatment).
- Hepatitis B Status: Inactive hepatitis B virus infection with negative HBV-DNA viral load.
- Informed Consent: Ability to understand and voluntarily sign the informed consent form.
- Prior Treatment: Failed prior standard treatment.
Key exclusion criteria (24 listed)
- Prior Treatment:
- Received systemic anti-tumor therapy (chemotherapy, radiotherapy, biological therapy, cytokine therapy, immunotherapy) or participated in other therapeutic clinical studies within 4 weeks prior to the first dose of the study drug. This includes nitrosourea drugs or mitomycin C within 6 weeks prior to the first dose. Exceptions: i) Oral fluoropyrimidine drugs or small molecule targeted agents received more than 2 weeks or 5 half-lives before the first dose (whichever is longer, but not exceeding 28 days).
- Traditional Chinese medicine for anti-tumor treatment received more than 2 weeks prior to the first dose.
- Palliative bone-directed radiotherapy. b) Planned to undergo major surgery within 28 days before the start of the study treatment (diagnostic biopsies are permitted).
- Received systemic immunostimulants within 4 weeks or 5 half-lives (whichever is longer) prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gene therapyUsing small nucleic acid drug to targeting CREPT | Genetic | CREPT-618 |
Primary outcome
Primary Objective
Time frame: From enrollment to the end of treatment at 12 weeks
Safety: Incidence of adverse events (AEs) (graded according to CTCAE v5.0)， Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)
10 secondary outcomes
Pharmacokinetics (PK)
Time frame: baseline and after treatment (0.5h, 1h, 2h, 4h, 8h, 24h for first dose, 1h for second dose(day15) and third dose(day 29))
Pharmacokinetics (PK)
Time frame: baseline and after treatment (0.5h, 1h, 2h, 4h, 8h, 24h for first dose, 1h for second dose(day15) and third dose(day 29))
Pharmacokinetics (PK)
Time frame: baseline and after treatment (0.5h, 1h, 2h, 4h, 8h, 24h for first dose, 1h for second dose(day15) and third dose(day 29))
Pharmacodynamics(PD)
Time frame: baseline and 6 weeks after treatment
Preliminary Efficacy
Time frame: about 2 years
Preliminary Efficacy
Time frame: about 2 years
Preliminary Efficacy
Time frame: about 2 years
Preliminary Efficacy
Time frame: at baseline and 15 days after treatment.
preliminary efficacy
Time frame: about 2 years
Preliminary Efficacy
Time frame: Baseline and 15 days after first treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ning Li, M.D. principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing gene therapy in people with Hepatocellular Carcinoma (HCC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peiwen Ma, M.D. (+86010-87788165, mapeiwen@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.